Loading…
PD-L1 testing of non-small cell lung cancer using different antibodies and platforms: a Swiss cross-validation study
With the approval of pembrolizumab for first- and second-line treatment of PD-L1+ non-small cell lung cancer (NSCLC), PD-L1 testing by immunohistochemistry (IHC) has become a necessity. However, the DAKO autostainer ASL48 for the FDA approved DAKO 22C3 pharmDx assay is not broadly available in Switz...
Saved in:
| Published in: | Virchows Archiv : an international journal of pathology 2019-07, Vol.475 (1), p.67-76 |
|---|---|
| Main Authors: | , , , , , , , , , , , , , , , , , |
| Format: | Article |
| Language: | English |
| Subjects: | |
| Citations: | Items that this one cites Items that cite this one |
| Online Access: | Get full text |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| cited_by | cdi_FETCH-LOGICAL-c419t-eb2f5667a2b5cccc68cb72e5574ed9c984332284fbc261f2a4e9be97933f93283 |
|---|---|
| cites | cdi_FETCH-LOGICAL-c419t-eb2f5667a2b5cccc68cb72e5574ed9c984332284fbc261f2a4e9be97933f93283 |
| container_end_page | 76 |
| container_issue | 1 |
| container_start_page | 67 |
| container_title | Virchows Archiv : an international journal of pathology |
| container_volume | 475 |
| creator | Savic, Spasenija Berezowska, Sabina Eppenberger-Castori, Serenella Cathomas, Gieri Diebold, Joachim Fleischmann, Achim Jochum, Wolfram Komminoth, Paul McKee, Thomas Letovanec, Igor Jasarevic, Zerina Rössle, Matthias Singer, Gad von Gunten, Michael Zettl, Andreas Zweifel, Roland Soltermann, Alex Bubendorf, Lukas |
| description | With the approval of pembrolizumab for first- and second-line treatment of PD-L1+ non-small cell lung cancer (NSCLC), PD-L1 testing by immunohistochemistry (IHC) has become a necessity. However, the DAKO autostainer ASL48 for the FDA approved DAKO 22C3 pharmDx assay is not broadly available in Switzerland and other parts of Europe. The primary goal of this study was to cross-validate the 22C3 anti-PD-L1 antibody on Benchmark Ultra (VBMU) and Leica Bond (LBO) immunostainers. IHC protocols were developed for 22C3 on both platforms with the 22C3phDx using ASL48 as reference. A tissue microarray (TMA) was constructed from 23 NSCLC specimens with a range of PD-L1 staining results. Empty TMA sections and the 22C3 antibody were distributed to 16 participants for staining on VBMU (8 centers) and/or LBO (12 centers) using the centrally developed protocols. Additionally the performance of the Ventana SP263 assay was tested in five centers. IHC scoring was performed centrally. Categorical PD-L1 staining (0–49% vs. 50–100%) did not significantly differ between centers using VBMU, whereas data from LBO were highly variable (
p
|
| doi_str_mv | 10.1007/s00428-019-02582-0 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2232089988</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2229805903</sourcerecordid><originalsourceid>FETCH-LOGICAL-c419t-eb2f5667a2b5cccc68cb72e5574ed9c984332284fbc261f2a4e9be97933f93283</originalsourceid><addsrcrecordid>eNp9kUuPFSEQhYnRONfRP-DCkLhxg0LRD3BnxmdyE03UNaFpmDDphitFj5l_L3fuqIkLWQApvjrUySHkqeAvBefjK-S8A8W40IxDr4Dxe2QnOgkMJB_vkx3XXc8GKcYz8gjxinMQSgwPyZkUAkap-h2pX96yvaDVY43pkuZAU04MV7ss1Pm2LVsrO5ucL3TDIzPHEHzxqVKbapzyHD2260wPi60hlxVfU0u__oyI1JWMyK7tEmdbY04U6zbfPCYPgl3QP7k7z8n39---XXxk-88fPl282TPXCV2ZnyD0wzBamHrX1qDcNILv-7Hzs3ZadVICqC5MDgYRwHZeT16PWsqgJSh5Tl6cdA8l_9iaRbNGPLqyyecNDYAErrRWR_T5P-hV3kpq0zUKtOK95rJRcKJufRUfzKHE1ZYbI7g5ZmJOmZiWibnNxPDW9OxOeptWP_9p-R1CA-QJwPaULn35-_d_ZH8BRXiXHQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2229805903</pqid></control><display><type>article</type><title>PD-L1 testing of non-small cell lung cancer using different antibodies and platforms: a Swiss cross-validation study</title><source>Springer Link</source><creator>Savic, Spasenija ; Berezowska, Sabina ; Eppenberger-Castori, Serenella ; Cathomas, Gieri ; Diebold, Joachim ; Fleischmann, Achim ; Jochum, Wolfram ; Komminoth, Paul ; McKee, Thomas ; Letovanec, Igor ; Jasarevic, Zerina ; Rössle, Matthias ; Singer, Gad ; von Gunten, Michael ; Zettl, Andreas ; Zweifel, Roland ; Soltermann, Alex ; Bubendorf, Lukas</creator><creatorcontrib>Savic, Spasenija ; Berezowska, Sabina ; Eppenberger-Castori, Serenella ; Cathomas, Gieri ; Diebold, Joachim ; Fleischmann, Achim ; Jochum, Wolfram ; Komminoth, Paul ; McKee, Thomas ; Letovanec, Igor ; Jasarevic, Zerina ; Rössle, Matthias ; Singer, Gad ; von Gunten, Michael ; Zettl, Andreas ; Zweifel, Roland ; Soltermann, Alex ; Bubendorf, Lukas</creatorcontrib><description>With the approval of pembrolizumab for first- and second-line treatment of PD-L1+ non-small cell lung cancer (NSCLC), PD-L1 testing by immunohistochemistry (IHC) has become a necessity. However, the DAKO autostainer ASL48 for the FDA approved DAKO 22C3 pharmDx assay is not broadly available in Switzerland and other parts of Europe. The primary goal of this study was to cross-validate the 22C3 anti-PD-L1 antibody on Benchmark Ultra (VBMU) and Leica Bond (LBO) immunostainers. IHC protocols were developed for 22C3 on both platforms with the 22C3phDx using ASL48 as reference. A tissue microarray (TMA) was constructed from 23 NSCLC specimens with a range of PD-L1 staining results. Empty TMA sections and the 22C3 antibody were distributed to 16 participants for staining on VBMU (8 centers) and/or LBO (12 centers) using the centrally developed protocols. Additionally the performance of the Ventana SP263 assay was tested in five centers. IHC scoring was performed centrally. Categorical PD-L1 staining (0–49% vs. 50–100%) did not significantly differ between centers using VBMU, whereas data from LBO were highly variable (
p
< 0.001). The SP263 assay was well concordant with 22C3 on VBMU and with 22C3 pharmDx. PD-L1 IHC using a standardized 22C3 protocol on VBMU provides satisfactory results in most centers. The SP263 assay is confirmed as a valid alternative to 22C3 pharmDx. 22C3 PD-L1 IHC on LBO shows major staining variability between centers, highlighting the need for local validation and adjustment of protocols.</description><identifier>ISSN: 0945-6317</identifier><identifier>EISSN: 1432-2307</identifier><identifier>DOI: 10.1007/s00428-019-02582-0</identifier><identifier>PMID: 31127385</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Antibodies ; Antibodies - immunology ; Assaying ; Automation, Laboratory ; B7-H1 Antigen - analysis ; Biomarkers, Tumor - analysis ; Carcinoma, Non-Small-Cell Lung - chemistry ; Carcinoma, Non-Small-Cell Lung - immunology ; Carcinoma, Non-Small-Cell Lung - pathology ; Humans ; Immunohistochemistry ; Immunohistochemistry - instrumentation ; Immunohistochemistry - methods ; Immunohistochemistry - standards ; Lung cancer ; Lung Neoplasms - chemistry ; Lung Neoplasms - immunology ; Lung Neoplasms - pathology ; Medicine ; Medicine & Public Health ; Monoclonal antibodies ; Non-small cell lung carcinoma ; Observer Variation ; Original Article ; Pathology ; PD-L1 protein ; Pembrolizumab ; Platforms ; Predictive Value of Tests ; Reproducibility of Results ; Staining ; Switzerland ; Targeted cancer therapy ; Tissue Array Analysis</subject><ispartof>Virchows Archiv : an international journal of pathology, 2019-07, Vol.475 (1), p.67-76</ispartof><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2019</rights><rights>Virchows Archiv is a copyright of Springer, (2019). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c419t-eb2f5667a2b5cccc68cb72e5574ed9c984332284fbc261f2a4e9be97933f93283</citedby><cites>FETCH-LOGICAL-c419t-eb2f5667a2b5cccc68cb72e5574ed9c984332284fbc261f2a4e9be97933f93283</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,27905,27906</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31127385$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Savic, Spasenija</creatorcontrib><creatorcontrib>Berezowska, Sabina</creatorcontrib><creatorcontrib>Eppenberger-Castori, Serenella</creatorcontrib><creatorcontrib>Cathomas, Gieri</creatorcontrib><creatorcontrib>Diebold, Joachim</creatorcontrib><creatorcontrib>Fleischmann, Achim</creatorcontrib><creatorcontrib>Jochum, Wolfram</creatorcontrib><creatorcontrib>Komminoth, Paul</creatorcontrib><creatorcontrib>McKee, Thomas</creatorcontrib><creatorcontrib>Letovanec, Igor</creatorcontrib><creatorcontrib>Jasarevic, Zerina</creatorcontrib><creatorcontrib>Rössle, Matthias</creatorcontrib><creatorcontrib>Singer, Gad</creatorcontrib><creatorcontrib>von Gunten, Michael</creatorcontrib><creatorcontrib>Zettl, Andreas</creatorcontrib><creatorcontrib>Zweifel, Roland</creatorcontrib><creatorcontrib>Soltermann, Alex</creatorcontrib><creatorcontrib>Bubendorf, Lukas</creatorcontrib><title>PD-L1 testing of non-small cell lung cancer using different antibodies and platforms: a Swiss cross-validation study</title><title>Virchows Archiv : an international journal of pathology</title><addtitle>Virchows Arch</addtitle><addtitle>Virchows Arch</addtitle><description>With the approval of pembrolizumab for first- and second-line treatment of PD-L1+ non-small cell lung cancer (NSCLC), PD-L1 testing by immunohistochemistry (IHC) has become a necessity. However, the DAKO autostainer ASL48 for the FDA approved DAKO 22C3 pharmDx assay is not broadly available in Switzerland and other parts of Europe. The primary goal of this study was to cross-validate the 22C3 anti-PD-L1 antibody on Benchmark Ultra (VBMU) and Leica Bond (LBO) immunostainers. IHC protocols were developed for 22C3 on both platforms with the 22C3phDx using ASL48 as reference. A tissue microarray (TMA) was constructed from 23 NSCLC specimens with a range of PD-L1 staining results. Empty TMA sections and the 22C3 antibody were distributed to 16 participants for staining on VBMU (8 centers) and/or LBO (12 centers) using the centrally developed protocols. Additionally the performance of the Ventana SP263 assay was tested in five centers. IHC scoring was performed centrally. Categorical PD-L1 staining (0–49% vs. 50–100%) did not significantly differ between centers using VBMU, whereas data from LBO were highly variable (
p
< 0.001). The SP263 assay was well concordant with 22C3 on VBMU and with 22C3 pharmDx. PD-L1 IHC using a standardized 22C3 protocol on VBMU provides satisfactory results in most centers. The SP263 assay is confirmed as a valid alternative to 22C3 pharmDx. 22C3 PD-L1 IHC on LBO shows major staining variability between centers, highlighting the need for local validation and adjustment of protocols.</description><subject>Antibodies</subject><subject>Antibodies - immunology</subject><subject>Assaying</subject><subject>Automation, Laboratory</subject><subject>B7-H1 Antigen - analysis</subject><subject>Biomarkers, Tumor - analysis</subject><subject>Carcinoma, Non-Small-Cell Lung - chemistry</subject><subject>Carcinoma, Non-Small-Cell Lung - immunology</subject><subject>Carcinoma, Non-Small-Cell Lung - pathology</subject><subject>Humans</subject><subject>Immunohistochemistry</subject><subject>Immunohistochemistry - instrumentation</subject><subject>Immunohistochemistry - methods</subject><subject>Immunohistochemistry - standards</subject><subject>Lung cancer</subject><subject>Lung Neoplasms - chemistry</subject><subject>Lung Neoplasms - immunology</subject><subject>Lung Neoplasms - pathology</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Monoclonal antibodies</subject><subject>Non-small cell lung carcinoma</subject><subject>Observer Variation</subject><subject>Original Article</subject><subject>Pathology</subject><subject>PD-L1 protein</subject><subject>Pembrolizumab</subject><subject>Platforms</subject><subject>Predictive Value of Tests</subject><subject>Reproducibility of Results</subject><subject>Staining</subject><subject>Switzerland</subject><subject>Targeted cancer therapy</subject><subject>Tissue Array Analysis</subject><issn>0945-6317</issn><issn>1432-2307</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><recordid>eNp9kUuPFSEQhYnRONfRP-DCkLhxg0LRD3BnxmdyE03UNaFpmDDphitFj5l_L3fuqIkLWQApvjrUySHkqeAvBefjK-S8A8W40IxDr4Dxe2QnOgkMJB_vkx3XXc8GKcYz8gjxinMQSgwPyZkUAkap-h2pX96yvaDVY43pkuZAU04MV7ss1Pm2LVsrO5ucL3TDIzPHEHzxqVKbapzyHD2260wPi60hlxVfU0u__oyI1JWMyK7tEmdbY04U6zbfPCYPgl3QP7k7z8n39---XXxk-88fPl282TPXCV2ZnyD0wzBamHrX1qDcNILv-7Hzs3ZadVICqC5MDgYRwHZeT16PWsqgJSh5Tl6cdA8l_9iaRbNGPLqyyecNDYAErrRWR_T5P-hV3kpq0zUKtOK95rJRcKJufRUfzKHE1ZYbI7g5ZmJOmZiWibnNxPDW9OxOeptWP_9p-R1CA-QJwPaULn35-_d_ZH8BRXiXHQ</recordid><startdate>20190701</startdate><enddate>20190701</enddate><creator>Savic, Spasenija</creator><creator>Berezowska, Sabina</creator><creator>Eppenberger-Castori, Serenella</creator><creator>Cathomas, Gieri</creator><creator>Diebold, Joachim</creator><creator>Fleischmann, Achim</creator><creator>Jochum, Wolfram</creator><creator>Komminoth, Paul</creator><creator>McKee, Thomas</creator><creator>Letovanec, Igor</creator><creator>Jasarevic, Zerina</creator><creator>Rössle, Matthias</creator><creator>Singer, Gad</creator><creator>von Gunten, Michael</creator><creator>Zettl, Andreas</creator><creator>Zweifel, Roland</creator><creator>Soltermann, Alex</creator><creator>Bubendorf, Lukas</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7T5</scope><scope>7T7</scope><scope>7TM</scope><scope>7TO</scope><scope>7U7</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88A</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M7P</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope></search><sort><creationdate>20190701</creationdate><title>PD-L1 testing of non-small cell lung cancer using different antibodies and platforms: a Swiss cross-validation study</title><author>Savic, Spasenija ; Berezowska, Sabina ; Eppenberger-Castori, Serenella ; Cathomas, Gieri ; Diebold, Joachim ; Fleischmann, Achim ; Jochum, Wolfram ; Komminoth, Paul ; McKee, Thomas ; Letovanec, Igor ; Jasarevic, Zerina ; Rössle, Matthias ; Singer, Gad ; von Gunten, Michael ; Zettl, Andreas ; Zweifel, Roland ; Soltermann, Alex ; Bubendorf, Lukas</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c419t-eb2f5667a2b5cccc68cb72e5574ed9c984332284fbc261f2a4e9be97933f93283</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Antibodies</topic><topic>Antibodies - immunology</topic><topic>Assaying</topic><topic>Automation, Laboratory</topic><topic>B7-H1 Antigen - analysis</topic><topic>Biomarkers, Tumor - analysis</topic><topic>Carcinoma, Non-Small-Cell Lung - chemistry</topic><topic>Carcinoma, Non-Small-Cell Lung - immunology</topic><topic>Carcinoma, Non-Small-Cell Lung - pathology</topic><topic>Humans</topic><topic>Immunohistochemistry</topic><topic>Immunohistochemistry - instrumentation</topic><topic>Immunohistochemistry - methods</topic><topic>Immunohistochemistry - standards</topic><topic>Lung cancer</topic><topic>Lung Neoplasms - chemistry</topic><topic>Lung Neoplasms - immunology</topic><topic>Lung Neoplasms - pathology</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Monoclonal antibodies</topic><topic>Non-small cell lung carcinoma</topic><topic>Observer Variation</topic><topic>Original Article</topic><topic>Pathology</topic><topic>PD-L1 protein</topic><topic>Pembrolizumab</topic><topic>Platforms</topic><topic>Predictive Value of Tests</topic><topic>Reproducibility of Results</topic><topic>Staining</topic><topic>Switzerland</topic><topic>Targeted cancer therapy</topic><topic>Tissue Array Analysis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Savic, Spasenija</creatorcontrib><creatorcontrib>Berezowska, Sabina</creatorcontrib><creatorcontrib>Eppenberger-Castori, Serenella</creatorcontrib><creatorcontrib>Cathomas, Gieri</creatorcontrib><creatorcontrib>Diebold, Joachim</creatorcontrib><creatorcontrib>Fleischmann, Achim</creatorcontrib><creatorcontrib>Jochum, Wolfram</creatorcontrib><creatorcontrib>Komminoth, Paul</creatorcontrib><creatorcontrib>McKee, Thomas</creatorcontrib><creatorcontrib>Letovanec, Igor</creatorcontrib><creatorcontrib>Jasarevic, Zerina</creatorcontrib><creatorcontrib>Rössle, Matthias</creatorcontrib><creatorcontrib>Singer, Gad</creatorcontrib><creatorcontrib>von Gunten, Michael</creatorcontrib><creatorcontrib>Zettl, Andreas</creatorcontrib><creatorcontrib>Zweifel, Roland</creatorcontrib><creatorcontrib>Soltermann, Alex</creatorcontrib><creatorcontrib>Bubendorf, Lukas</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Immunology Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Nucleic Acids Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Biology Database (Alumni Edition)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>Biological Science Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><jtitle>Virchows Archiv : an international journal of pathology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Savic, Spasenija</au><au>Berezowska, Sabina</au><au>Eppenberger-Castori, Serenella</au><au>Cathomas, Gieri</au><au>Diebold, Joachim</au><au>Fleischmann, Achim</au><au>Jochum, Wolfram</au><au>Komminoth, Paul</au><au>McKee, Thomas</au><au>Letovanec, Igor</au><au>Jasarevic, Zerina</au><au>Rössle, Matthias</au><au>Singer, Gad</au><au>von Gunten, Michael</au><au>Zettl, Andreas</au><au>Zweifel, Roland</au><au>Soltermann, Alex</au><au>Bubendorf, Lukas</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>PD-L1 testing of non-small cell lung cancer using different antibodies and platforms: a Swiss cross-validation study</atitle><jtitle>Virchows Archiv : an international journal of pathology</jtitle><stitle>Virchows Arch</stitle><addtitle>Virchows Arch</addtitle><date>2019-07-01</date><risdate>2019</risdate><volume>475</volume><issue>1</issue><spage>67</spage><epage>76</epage><pages>67-76</pages><issn>0945-6317</issn><eissn>1432-2307</eissn><abstract>With the approval of pembrolizumab for first- and second-line treatment of PD-L1+ non-small cell lung cancer (NSCLC), PD-L1 testing by immunohistochemistry (IHC) has become a necessity. However, the DAKO autostainer ASL48 for the FDA approved DAKO 22C3 pharmDx assay is not broadly available in Switzerland and other parts of Europe. The primary goal of this study was to cross-validate the 22C3 anti-PD-L1 antibody on Benchmark Ultra (VBMU) and Leica Bond (LBO) immunostainers. IHC protocols were developed for 22C3 on both platforms with the 22C3phDx using ASL48 as reference. A tissue microarray (TMA) was constructed from 23 NSCLC specimens with a range of PD-L1 staining results. Empty TMA sections and the 22C3 antibody were distributed to 16 participants for staining on VBMU (8 centers) and/or LBO (12 centers) using the centrally developed protocols. Additionally the performance of the Ventana SP263 assay was tested in five centers. IHC scoring was performed centrally. Categorical PD-L1 staining (0–49% vs. 50–100%) did not significantly differ between centers using VBMU, whereas data from LBO were highly variable (
p
< 0.001). The SP263 assay was well concordant with 22C3 on VBMU and with 22C3 pharmDx. PD-L1 IHC using a standardized 22C3 protocol on VBMU provides satisfactory results in most centers. The SP263 assay is confirmed as a valid alternative to 22C3 pharmDx. 22C3 PD-L1 IHC on LBO shows major staining variability between centers, highlighting the need for local validation and adjustment of protocols.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>31127385</pmid><doi>10.1007/s00428-019-02582-0</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0945-6317 |
| ispartof | Virchows Archiv : an international journal of pathology, 2019-07, Vol.475 (1), p.67-76 |
| issn | 0945-6317 1432-2307 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2232089988 |
| source | Springer Link |
| subjects | Antibodies Antibodies - immunology Assaying Automation, Laboratory B7-H1 Antigen - analysis Biomarkers, Tumor - analysis Carcinoma, Non-Small-Cell Lung - chemistry Carcinoma, Non-Small-Cell Lung - immunology Carcinoma, Non-Small-Cell Lung - pathology Humans Immunohistochemistry Immunohistochemistry - instrumentation Immunohistochemistry - methods Immunohistochemistry - standards Lung cancer Lung Neoplasms - chemistry Lung Neoplasms - immunology Lung Neoplasms - pathology Medicine Medicine & Public Health Monoclonal antibodies Non-small cell lung carcinoma Observer Variation Original Article Pathology PD-L1 protein Pembrolizumab Platforms Predictive Value of Tests Reproducibility of Results Staining Switzerland Targeted cancer therapy Tissue Array Analysis |
| title | PD-L1 testing of non-small cell lung cancer using different antibodies and platforms: a Swiss cross-validation study |
| url | http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-19T17%3A02%3A01IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=PD-L1%20testing%20of%20non-small%20cell%20lung%20cancer%20using%20different%20antibodies%20and%20platforms:%20a%20Swiss%20cross-validation%20study&rft.jtitle=Virchows%20Archiv%20:%20an%20international%20journal%20of%20pathology&rft.au=Savic,%20Spasenija&rft.date=2019-07-01&rft.volume=475&rft.issue=1&rft.spage=67&rft.epage=76&rft.pages=67-76&rft.issn=0945-6317&rft.eissn=1432-2307&rft_id=info:doi/10.1007/s00428-019-02582-0&rft_dat=%3Cproquest_cross%3E2229805903%3C/proquest_cross%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c419t-eb2f5667a2b5cccc68cb72e5574ed9c984332284fbc261f2a4e9be97933f93283%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=2229805903&rft_id=info:pmid/31127385&rfr_iscdi=true |